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Amylin Drug

Amylin Partner Blocked From Selling Competing Diabetes Drug

Amylin Partner Blocked From Selling Competing Diabetes Drug

Amylin partner blocked from selling competing diabetes drug A federal judge temporarily blocked a key Amylin Pharmaceuticals partner from selling a new type 2 diabetes drug that would directly compete with the San Diego company's main prescription product. The temporary restraining order marked an early victory for Amylin in a legal battle that erupted earlier this month after the Food and Drug Administration approved Boehringer Ingelheim's Tradjenta, a prescription pill taken once a day for at least six months. Amylin partner Eli Lilly and the German drugmaker entered into an alliance in January to develop and sell Tradjenta and other potential therapies in Boehringers diabetes portfolio. In its lawsuit, Amylin said that deal violated terms of the San Diego company's nine-year partnership with Lilly to sell its main drug, Byetta, a twice-daily injection. The court order indicated that Lilly planned for 60 percent of its 1,144 sales representatives to promote Tradjenta over Byetta, stock analyst Mark Schoenebaum said in a Thursday morning note to investors. "We suspect this infuriated Amylin," he said "It also suggests that Lilly thinks (Tradjenta) will be bigger than Byetta (and a once-weekly version of the drug in development), in our view." Amylin disclosed the court order early Thursday morning in a filing with the Securities and Exchange Commission . Shares of Amylin were down 22 cents, or nearly 2 percent, to $13.11 in early trading. Byetta has been losing market share to competitors that require less frequent injections, and the company has been under pressure to get a longer-lasting version of Byetta onto the market. A weekly injectable version of the drug, dubbed Bydureon, was rejected in October by the FDA, which told the company to conduct a new study of how Continue reading >>

Amylin Analog Treatment

Amylin Analog Treatment

Pramlintide helps control blood sugar levels after eating. Pramlintide resembles amylin, which is normally released along with insulin from the pancreas. Pramlintide is an injected medicine for people with type 1 and type 2 diabetes that helps control blood sugar levels after eating. Pramlintide (Symlin) Pramlintide resembles the hormone, amylin that is normally released along with insulin from the pancreas. In type 2 diabetes, amylin levels may be reduced. Some people get certain side effects (such as nausea, vomiting and low blood sugar) when starting pramlintide, therefore the starting dose is small to allow the body to adjust to this new medicine. In short, pramlintide lowers glucagon during a meal, slows food emptying from the stomach and curbs the appetite. Side Effects Some people get certain side effects (such as nausea, vomiting and low blood sugar) when starting pramlintide, therefore the starting dose is small to allow the body to adjust to this new medicine. In type 2 diabetes, the initial dose is 60 micrograms (10 units on the insulin syringe), taken before meals. After 3 days, if you tolerate the medicine, the dose may be increased to 120 micrograms (20 units on the insulin syringe) before meals. Pramlintide is available in a vial and pen form. If you are treated with insulin releasing pills and starting pramlintide: Reduce the insulin releasing pill dose by half or more. Ask your medical provider for exact recommendation. Inject pramlintide just before eating; it is taken three times daily. If you are treated with insulin and starting pramlintide: Reduce your mealtime insulin dose by half or more to prevent a low blood sugar. Ask your medical provider for exact recommendation. If using an insulin pump, extending the meal bolus to 1 ½ or 2 hours may preve Continue reading >>

Pramlintide, The Synthetic Analogue Of Amylin: Physiology, Pathophysiology, And Effects On Glycemic Control, Body Weight, And Selected Biomarkers Of Vascular Risk

Pramlintide, The Synthetic Analogue Of Amylin: Physiology, Pathophysiology, And Effects On Glycemic Control, Body Weight, And Selected Biomarkers Of Vascular Risk

Pramlintide, the synthetic analogue of amylin: physiology, pathophysiology, and effects on glycemic control, body weight, and selected biomarkers of vascular risk Byron J Hoogwerf , Krupa B Doshi , and Dima Diab Department of Endocrinology, Diabetes and Metabolism, Cleveland Clinic Foundation, Cleveland, USA Correspondence: Byron J Hoogwerf Desk A-53, 9500 Euclid Ave, Cleveland, OH, USA Tel +1 216 444 8347 Fax +1 216 445 1656 Email gro.fc[email protected] Copyright 2008 Dove Medical Press Limited. All rights reserved This article has been cited by other articles in PMC. Pramlintide is a synthetic version of the naturally occurring pancreatic peptide called amylin. Amylin and pramlintide have similar effects on lowering postprandial glucose, lowering postprandial glucagon and delaying gastric emptying. Pramlintide use in type 1 and insulin requiring type 2 diabetes mellitus (DM) is associated with modest reductions in HbA1c often accompanied by weight loss. Limited data show a neutral effect on blood pressure. Small studies suggest small reductions in LDL-cholesterol in type 2 DM and modest reductions in triglycerides in type 1 DM. Markers of oxidation are also reduced in conjunction with reductions in postprandial glucose. Nausea is the most common side effect. These data indicate that pramlintide has a role in glycemic control of both type 1 and type 2 DM. Pramlintide use is associated with favorable effects on weight, lipids and other biomarkers for atherosclerotic disease. Keywords: pramlintide, glycemic control, diabetes mellitus The benefits of glycemic control on reducing the risk for microvascular complications are now quite well established from both observational data sets and intervention trials ( DCCT Research Group 1993 , 2001 ; DCCT/EDIC Research Group 2000 ; UKPD Continue reading >>

Amylin

Amylin

Insulin's Super Sidekick Batman has Robin. The Lone Ranger has Tonto. And insulin has its own tough little partner: a hormone called amylin. What’s that? You thought insulin worked alone, like Superman or Spiderman? Think again. Those guys only had madmen and criminals to fight. Insulin has the onerous task of keeping blood glucose in check while fending off challenges from food, stress, illness, and a slew of other hormones. However, like most sidekicks, amylin cannot replace or outperform insulin. Instead, it supplements insulin’s actions and allows insulin to do its job more effectively. This is particularly true after meals, when insulin by itself is no match for the blood glucose onslaught brought on by carbohydrates (sugars and starches) in the meal. How it works As most people with diabetes already know, insulin helps transfer glucose out of the bloodstream and into the body’s cells. It is produced by a group of cells in the pancreas called beta cells. But beta cells secrete more than just insulin; they also secrete amylin. People with Type 1 diabetes, whose beta cells have been destroyed by the body’s immune system, secrete no amylin at all. And people with Type 2 diabetes who have progressed to the point of needing insulin injections (or infusions from a pump) have limited beta cell capacity and thus produce insufficient amylin. So why all the fuss about amylin? Those of us with diabetes have survived for years without it. But the goal, of course, is more than just survival. It is to manage blood glucose levels effectively so that we feel good, can perform our daily routines, and live long, healthy, productive lives. The natural hormone amylin, as well as its synthetic equivalent, pramlintide (available since 2005 under the brand name Symlin), helps imp Continue reading >>

Amylin Agonists - Anti-hyperglycemic Synthetic Analogs

Amylin Agonists - Anti-hyperglycemic Synthetic Analogs

SYMLIN is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia associated with SYMLIN use occurs, it is seen within 3 hours following a SYMLIN injection. If severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities, serious injuries may occur. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk. SYMLIN, by acting as an amylinomimetic agent, has the following effects: 1) modulation of gastric emptying; 2) prevention of the postprandial rise in plasma glucagon; and 3) satiety leading to decreased caloric intake and potential weight loss. The gastric-emptying rate is an important determinant of the postprandial rise in plasma glucose. SYMLIN slows the rate at which food is released from the stomach to the small intestine following a meal and, thus, it reduces the initial postprandial increase in plasma glucose. This effect lasts for approximately 3 hours following SYMLIN administration. SYMLIN does not alter the net absorption of ingested carbohydrate or other nutrients. In patients with diabetes, glucagon concentrations are abnormally elevated during the postprandial period, contributing to hyperglycemia. SYMLIN has been shown to decrease postprandial glucagon concentrations in insulin-using patients with diabetes. SYMLIN administered prior to a meal has been shown to reduce total caloric intake. This effect appears to be independent of the nausea that can accompany SYMLIN treatment SYMLIN is given at mealtimes and is indicated for: Type 1 diabetes, as an adjunct treatment in patients who use mealtime i Continue reading >>

Fda Seeks Data On Delivery Method For Amylin Drug

Fda Seeks Data On Delivery Method For Amylin Drug

FDA seeks data on delivery method for Amylin drug (Reuters) - Amylin Pharmaceuticals Inc said U.S. health regulators have requested data on a new delivery system for its recently approved long-acting diabetes drug Bydureon. Amylin, which is seeking approval for the new pen-delivery system as an alternative to the current needle injections, said in a regulatory filing on Tuesday that it received comments from the Food and Drug Administration on its application, including a request for incremental device-related data. The biotech company, which is taking bids from potential buyers seeking to acquire Amylin and its diabetes franchise, said it would respond to the FDA in a timely fashion. Amylin also said it hopes to have the Bydureon pen-delivery system available to patients in 2013. In January - after lengthy delays - the FDA approved Bydureon, a once weekly version of Amylins older Type 2 diabetes drug Byetta, known chemically as exenatide. Patients currently have to fill their own syringe before injecting Bydureon. The pen-delivery system has the drug pre-filled, making it potentially more convenient for diabetics. Amylins stock fell 1.1 percent in extended-hours trading to $27.05 from its Nasdaq close at $27.35. During the regular session, the stock gained 72 cents, or 2.7 percent. Reporting by Bill Berkrot; Editing by Gary Hill and Jan Paschal Continue reading >>

Amylin Analogues - Usage, Suitability, Benefits & Side Effects

Amylin Analogues - Usage, Suitability, Benefits & Side Effects

Amylin is produced by the pancreas and assists insulin in controlling post-meal glucose levels Amylin analogues, or agonists, are injectable drugs used in the treatment of both type 1 diabetes and type 2 diabetes . These compounds are administered before meals, and work similarly to the hormone amylin. Amylin has a number of benefits in terms of weight loss and reducing blood glucose levels. Amylin analogues are clinically available in the United States but not in the UK. In the US, Pramlintide acetate (marketed as Symlin ) is the only available drug in this class. Like insulin , it is administered by subcutaneous injection. Amylin is an amino acid polypeptide hormone that is produced by the pancreas and released at the same time as insulin, but in much smaller quantities (about 1% compared with insulin). The hormone assists insulin in controlling post-meal glucose levels. It inhibits the release of glucagon when eating, slows food emptying from the stomach and curbs appetite. Amylin agonists mimic these functions and have been shown to significantly reduce weight, average long-term blood glucose values ( HbA1c ), and even insulin doses for insulin-taking diabetics. In the UK, amylin has not been approved by NICE for use on prescription but in the USA, amylin has been used as an additional medication for people with type 1 and type 2 diabetes. One reason for amylin not having approval in the UK is that it can significantly raise the risk of severe hypoglycemia . Amylin has a number of actions which can help to lower blood glucose levels and promote weight loss including reducing appetite, slowing digestion including delaying emptying of the stomach and suppressing the release of glucagon. By blocking the release of glucagon, amylin can stop the body from raising blood Continue reading >>

Amylinomimetics For Diabetes

Amylinomimetics For Diabetes

Amylinomimetics may be used for type 1 or type 2 diabetes . Pramlintide is given as an injection before a meal. Pramlintide is always used with insulin , but the injections are given separately. Amylinomimetics work with insulin to control blood sugars after meals. This medicine slows down food moving through your stomach and slows down sugars moving into your blood . Pramlintide also lowers your appetite and can help you maintain a healthy weight . Amylinomimetics are synthetic drugs that act like a naturally occurring hormone called amylin. People with type 1 diabetes do not make amylin. People with type 2 diabetes who need insulin do not make enough amylin. This medicine is given at mealtimes. It may reduce the amount of insulin you need, especially before eating. Amylinomimetics do not replace insulin. This medicine works with insulin to help you control your blood sugar after eating. Amylinomimetics used with insulin can improve blood sugar control for people with type 1 and type 2 diabetes. Some people feel more full after eating, so they eat less and lose weight. All medicines have side effects. But many people don't feel the side effects, or they are able to deal with them. Ask your pharmacist about the side effects of each medicine you take. Side effects are also listed in the information that comes with your medicine. Here are some important things to think about: Usually the benefits of the medicine are more important than any minor side effects. Side effects may go away after you take the medicine for a while. If side effects still bother you and you wonder if you should keep taking the medicine, call your doctor. He or she may be able to lower your dose or change your medicine. Do not suddenly quit taking your medicine unless your doctor tells you to. See Continue reading >>

Fda Oks Amylin Drug For Diabetes

Fda Oks Amylin Drug For Diabetes

Symlin becomes the first new treatment in 80 years for patients with Type 1 of the disease. March 17, 2005 |Denise Gellene | Times Staff Writer Regulators approved Amylin Pharmaceuticals Inc.'s diabetes drug Symlin on Wednesday after an 18-year quest that investors had once written off as hopeless. It was the first Food and Drug Administration endorsement for the small San Diego company, which was close to closing seven years ago after a clinical trial of Symlin went badly. Amylin shares surged nearly 20% in after-hours trading. The approval was announced after the market closed. "This has been a trailblazing experience, arduous and very emotional," said Ginger Graham, Amylin's chief executive. "Today is one of the best days in the company's history." Symlin is a synthetic version of the natural hormone amylin, which works with insulin to control the flow of sugar from food into the bloodstream. It was approved for use by the estimated 4.5 million diabetics in the U.S. who use insulin to control their disease. It will carry a boxed warning about the risk of hypoglycemia, or low blood sugar. Concern about low blood sugar was one reason why it took the FDA so long to approve the drug. Low blood sugar can lead to confusion and brain injury. In an early clinical trial, one patient died in a car accident that regulators said might have been related to low blood sugar. Indeed, analysts said FDA approval hadn't been viewed as a sure thing on Wall Street. Jim Birchenough of Lehman Bros. said there was speculation that the agency would become cautious after the abrupt withdrawal from the market of the multiple sclerosis drug Tysabri this month. "It really weighed on Amylin's shares," he said. Now, he said, Amylin is poised to become a leader in diabetes, a disease that affects Continue reading >>

Amylin Diabetes Drug Improves Learning, Memory In Alzheimer's Mice

Amylin Diabetes Drug Improves Learning, Memory In Alzheimer's Mice

Amylin diabetes drug improves learning, memory in Alzheimer's mice A drug developed by Amylin Pharmaceuticals to treat diabetes may also have Alzheimer's-fighting properties, according to a new study. Researchers from Boston University School of Medicine have found that the diabetes drug pramlintide reduces neurotoxic amyloid- peptides, the main component of amyloid- plaques that afflict the brains of Alzheimer's patients, in experimental Alzheimer's models. Doses of the drug, an analogue of the small peptide hormone amylin, also improved learning and memory in mice. The findings, which were published online March 11 in Molecular Psychiatry, also found that Alzheimer's patients have a lower level of amylin, which is naturally occurring and produced by the pancreas, in the blood compared to those without this disease. "Surprisingly, injections of amylin or pramlintide into the AD models reduced the amyloid burden as well as lowered the concentrations of amyloid- peptides, a major component of AD in the brain," said Dr. Wendy Qiu, associate professor of psychiatry and pharmacology and experimental therapeutics at Boston University School of Medicine, in a statement. "It can easily cross the blood-brain barrier and has shown favorable safety profile for diabetes patients." The Alzheimer's field has been marked by setbacks because of high costs and failure rates, and one factor that has vexed drug developers is that drugs do not penetrate into the brain, making them ineffective for treating Alzheimer's. The researchers believe their findings support the use of a therapeutic application of amylin-class peptides for Alzheimer's. Qiu and her team hope to launch a clinical trial to study the effects of pramlintide on patients with Alzheimer's. "There is broad agreement that mo Continue reading >>

Xconomy: Amylin Resurrects Obesity Drug, In New Combination With Diabetes Drug Symlin

Xconomy: Amylin Resurrects Obesity Drug, In New Combination With Diabetes Drug Symlin

Amylin Resurrects Obesity Drug, in New Combination with Diabetes Drug Symlin Leptin was hailed as a magic bullet for obesity based on rat studies in the 1990s, and then it failed miserably when Amgen took it into clinical trials. Now Amylin Pharmaceuticals thinks it has found a way to bring leptin back to life as a weight-loss drug, as part of a new combination with Symlin, a drug it markets for diabetes. San Diego-based Amylin (NASDAQ: AMLN ) is presenting data on its new combination weight-loss drug this weekend at The Obesity Societys annual meeting in Phoenix, AZ. I got an overview of what Amylin will present there about its experimental treatment during an interview with Christian Weyer, the companys vice president of corporate development for diabetes and obesity. The opportunity, and risk, here is huge. About two-thirds of American adults are overweight or obese, according to the Centers for Disease Control and Prevention. The pharmaceutical industry has a history of failures here, and the most-prescribed treatment is still an appetite suppressant from the 1950s that causes side effects like nervousness and sleep problems, Weyer said. Since any new obesity drug will be taken by millions on a chronic basis, its safety has be squeaky clean. Madison, NJ-based Wyeth learned the hard way what happens when its not. The drugmaker has shelled out more than $21 billion in legal settlements after its fen-phen obesity drug combination was found to damage heart valves in some patients in the 1990s, according to its most recent quarterly report. And France-based Sanofi-Aventis had its Acomplia medicine rejected by FDA advisers last year after reports of suicidal thinking were linked to the drug. Safety is absolutely paramount in obesity drug development, Weyer says. The idea Continue reading >>

Astrazeneca To Acquire Bristol-myers Squibb Share Of Global Diabetes Alliance Assets

Astrazeneca To Acquire Bristol-myers Squibb Share Of Global Diabetes Alliance Assets

AstraZeneca to acquire Bristol-Myers Squibb share of global diabetes alliance assets Global agreement strengthens AstraZenecas commitment to diabetes, a key growth platform in a core strategic area for the company AstraZeneca today announced an agreement under which AstraZeneca will acquire the entirety of Bristol-Myers Squibbs interests in the companies diabetes alliance for an initial consideration of $2.7 billion on completion and up to $1.4 billion in regulatory, launch and sales-related payments. AstraZeneca has also agreed to pay various sales-related royalty payments up until 2025. In addition, AstraZeneca may make payments up to $225 million when certain assets are subsequently transferred. Upon completion of the transaction, AstraZeneca will own intellectual property and global rights for the development, manufacture and commercialisation of the diabetes business, which includes Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin HCl extended release), Komboglyze (saxagliptin and metformin HCl), dapagliflozin (marketed as Forxiga outside the US), Byetta (exenatide), Bydureon (exenatide extended-release for injectable suspension), metreleptin and Symlin (pramlintide acetate). The transaction will consolidate worldwide ownership of the diabetes business within AstraZeneca leveraging its primary and specialty care capabilities and its geographical reach, especially in emerging markets. The agreement reinforces AstraZenecas long-term commitment to patients with diabetes, a core strategic area and an important platform for returning AstraZeneca to growth. Based on the anticipated timing of the close, the transaction will have no impact on AstraZenecas guidance for Core EPS for 2013. The company expects the transaction when implemented to be neutral to C Continue reading >>

Xconomy: Amylin, Dark Horse Of The Obesity Drug Battle, Follows Fast Behind Arena, Orexigen

Xconomy: Amylin, Dark Horse Of The Obesity Drug Battle, Follows Fast Behind Arena, Orexigen

Amylin, Dark Horse of the Obesity Drug Battle, Follows Fast Behind Arena, Orexigen The competition to create new obesity drugs is usually portrayed as a three-way battle royal among San Diegos Arena Pharmaceuticals , crosstown rival Orexigen Therapeutics , and Mountain View, CA-based Vivus . Yet theres one more San Diego biotech company with a drug in an earlier phase of development, Amylin Pharmaceuticals , which may just have the most effective weight loss drug of the bunch. This is the story of Amylins effort to resurrect one of the biotech industrys notorious flame-outs of the 1990sleptin. We first told the tale back in October of how Amylin plucked this drug from Amgens scrap heap , reimagined it in tandem with its diabetes drug pramlintide (Symlin), and took another shot to see if leptin would ever live up to all that misplaced hype from years ago. Obesity is one of the nations biggest public health problems, and drug companies know the winner in this category might dominate the biggest pharmaceutical market ever. In this couch-loving, junk-food eating culture, health officials now say two-thirds of U.S. adults have become overweight or obese. Yet Big Pharma has been gun shy about this market opportunity since Wyeth was burned by the multi-billion legal payments related to heart damage patients suffered from the fen-phen drug combo in the 1990s, and Sanofi-Aventis failed to win approval two years ago for a drug that was linked to rare cases of suicidal thoughts. If any of the new contenders can assure the FDA their drugs are truly safe, obesity drugs will again become a popular culture tsunami, and will be pitched as a catch-all for illnesses related to obesitylike diabetes, high blood pressure, high cholesterol, and depression. Leptin was once hailed as the magi Continue reading >>

Amylin Pharmaceutical West Chester, Ohio, Usa

Amylin Pharmaceutical West Chester, Ohio, Usa

Amylin has received over $117m in benefits and assistance for locating its manufacturing facility in Ohio. Amylin Pharmaceuticals is a biopharmaceutical firm located in San Diego, California, with over 1,000 employees in the US. Amylin has developed and gained approval for two first-in-class medicines for the treatment of type I and type II diabetes, Symlin (pramlintide acetate) injection and Byetta (exenatide) injection. Amylin made a commitment in the third quarter of 2005 to invest $400m and create 500 jobs in Hamilton, West Chester, Butler County, Ohio, by setting up a new manufacturing facility to produce Byetta. The new biopharma manufacturing site, which was completed by the end of 2008, cost $400m to set up and outfit. It is being operated as a subsidiary of the main company, Amylin Ohio LLC. Initially 50 high-tech key personnel have been employed at the facility, with plans to expand the workforce over three years. The main facility is being located in an existing building at 8814 Trade Port Drive with a floor space of 151,200ft. Some construction was required on the 26-acre site to provide service buildings, warehousing and office space. The building and site cost was $9m. The first phase of the project began in January 2006. In 2007, Amylin bought an additional 17 acres for $4.5m. Since the third quarter of 2008, the facility has been manufacturing exenatide once every week. The supply of clinical trials with these materials had also begun. The facilitys design, construction and validation have been undertaken by Parsons, a group with substantial design and construction experience. The installation of filling, sterilisation and other production equipment also began at the end of 2008. A pre-approval inspection of the facility was conducted by the FDA in 2009 Continue reading >>

Amylin Analogs

Amylin Analogs

Amylin is a hormone secreted by the pancreas Amylin is secreted with insulin in response to food consumption Amylin has the following physiological effects: Slows gastric emptying (the rate at which food is emptied from the stomach into the small intestine) Suppresses glucagon secretion (glucagon stimulates glucose release from the liver) Pramlintide is a synthetic version of amylin Symlin is indicated as an adjunctive treatment in patients with type one or type two diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy Insulin doses (basal and premeal) did not change significantly in either group during the trial Pramlintide added to insulin and oral meds Pramlintide tends to cause a small amount of weight loss A review of pramlintide trials in the Annals of Family Medicine found that patients on pramlintide lost an average of 1 - 4 pounds [2] Pramlintide does not appear to have a significant effect on lipid parameters [4] There have been no long-term studies evaluating the effects of pramlintide on clinical outcomes The ADA 2018 diabetes guidelines state that pramlintide may be tried in specific situations, but is generally not favored due to modest efficacy, frequency of administration, cost, and side effects See ADA treatment recommendations for more There are no long-term safety and clinical outcome data on pramlintide More studies are needed before conclusions about pramlintide can be drawn Insulin doses (basal and premeal) did not change significantly in either group during the trial Pramlintide tends to cause a small amount of weight loss A review of pramlintide trials in the Annals of Family Medicine found that Type 1 diabetics on pramlintide lost an average of 1 - 3 pounds [2] Pramlinti Continue reading >>

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